Summary

The study aims to show that the candidate malariavaccine GMZ2 is as safe as the already
publicly used vaccine against rabies. 40 adult male Gabonese volunteers will be enrolled and
randomly allocated to receive either malaria vaccine or rabies vaccine without the
investigator or the participants knowing what they received. They will receive 3 doses each
at one month intervals, and will be followed up for one year to evaluate safety parameters.

This is the first time this product will be tested in Africa

Description

Background. GMZ2 is a recombinant hybrid of the Glutamate Rich Protein (GLURP) and the
Merozoite Surface Protein 3 (MSP 3).This product has been developed at Sate Serum Institute
in Denmark and Bacth released by Henogen of Belgium. The phase Ia trial in malaria naive
volunteers is currently ongoing in Germany, at Tuebingen University. This phase Ia trial
will establish safety of the vaccine and also select the best dosage (10, 30 or 100 µg). The
dosage with the best safety and immunogenicity profile will be recommended for the phase Ib
trial in Gabon.

2. Study Design This will be a single center, randomized, blinded and controlled study
involving 40 adult male volunteers. The entire study duration will be 16 months with each
participant remaining 13 months in the study.There will be 15 scheduled hospital visits and
11 scheduled field worker home visits. The Rabies vaccine will be used as control vaccine.

3. Objectives:

- The primary objective of this trial to evaluate the safety of 3 doses of GMZ2 when
administered on Days 0, 28 & 56, adjuvanted with aluminum hydroxide in healthy Gabonese
adults.

- Secondary objectives include the following: (i). To assess the humoral response to the
vaccine antigens GLURP and MSP3 by measuring the antibody response by ELISA and IFA.

(ii). To assess the cellular immune response by profiling the Th1/Th2-type cytokines after
24 and 48 hours stimulation.

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Medical and Biotech [MESH] Definitions

Diphtheria-tetanus Vaccine

A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.

Poliovirus Vaccine, Oral

A live vaccine containing attenuated poliovirus, types I, II, and III, grown in monkey kidney cell tissue culture, used for routine immunization of children against polio. This vaccine induces long-lasting intestinal and humoral immunity. Killed vaccine induces only humoral immunity. Oral poliovirus vaccine should not be administered to immunocompromised individuals or their household contacts. (Dorland, 28th ed)

Brucella Vaccine

A bacterial vaccine for the prevention of brucellosis in man and animal. Brucella abortus vaccine is used for the immunization of cattle, sheep, and goats.

Mumps Vaccine

A live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had mumps or been immunized with live mumps vaccine. Children are usually immunized with measles-mumps-rubella combination vaccine.

Measles Vaccine

A live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had measles or been immunized with live measles vaccine and have no serum antibodies against measles. Children are usually immunized with measles-mumps-rubella combination vaccine. (From Dorland, 28th ed)

Relevant Topics

MalariaMalaria is a serious tropical disease spread by mosquitoes. If malaria is not diagnosed and treated promptly, it can be fatal.
What causes malaria?
Malaria is caused by a type of parasite known as Plasmodium. There are many different types of Plasmod...

VaccineA vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one ...